TMP Left Atrial Pressure Cath Cat.# 100-00X-000
FDA 510(k) K904491 · Lifestream Int'L, Inc.
510(k) numberK904491
Submission
- Device name
- TMP Left Atrial Pressure Cath Cat.# 100-00X-000
- Applicant
- Lifestream Int'L, Inc.
The Woodlands, TX, US - Received
- October 2, 1990
- Decision date
- February 1, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DQO – Catheter, Intravascular, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
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Questions and answers
When was TMP Left Atrial Pressure Cath Cat.# 100-00X-000 cleared by the FDA?
TMP Left Atrial Pressure Cath Cat.# 100-00X-000 (K904491) received a 510(k) decision of Substantially Equivalent on February 1, 1991, 122 days after the submission was received.
What is the product code of K904491?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.